FDA-Drug2016-04-13Class II
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .
Meditech Laboratories, Inc
Hazard
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Sold states
Nationwide
Affected count
1320 vials - all formulas
Manufactured in
3200 Polaris Ave Ste 27, N/A, Las Vegas, NV, United States
Products
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0803-2016Don't want to check this manually?
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